ISO/IEC 17011:2017 適合性評価  —  適合性評価機関を認定する認定機関の要件 | ページ 6

3.1

accreditation

third-party attestation related to a conformity assessment body (3.4) conveying formal demonstration of its competence to carry out specific conformity assessment tasks

[SOURCE:ISO/IEC 17000:2004, 5.6]

3.2

accreditation body

authoritative body that performs accreditation (3.1)

Note 1 to entry: The authority of an accreditation body is generally derived from government.

[SOURCE:ISO/IEC 17000:2004, 2.6]

3.3

accreditation body logo

logo used by an accreditation body (3.2) to identify itself

3.4

conformity assessment body

body that performs conformity assessment activities and that can be the object of accreditation (3.1)

Note 1 to entry: Whenever the term “conformity assessment body” is used in the text, it applies to both the applicant and accredited conformity assessment bodies, unless otherwise specified.

[SOURCE:ISO/IEC 17000:2004, 2.5, modified — The words “and that can be the object of accreditation” have been added to the definition and the Note to entry has been added.]

3.5

conformity assessment activity

activity conducted by a conformity assessment body (3.4) when assessing conformity

Note 1 to entry: In the context of this document, activities covered by accreditation (3.1) include, but are not limited to, testing, calibration, inspection, certification of management systems, persons, products, processes and services, provision of proficiency testing, production of reference materials, validation and verification. For simplicity, these are referred to as conformity assessment activities being performed by conformity assessment bodies.

3.6

scope of accreditation

specific conformity assessment activities for which accreditation (3.1) is sought or has been granted

3.7

flexible scope of accreditation

scope of accreditation (3.6) expressed to allow conformity assessment bodies to make changes in methodology and other parameters which fall within the competence of the conformity assessment body (3.4) as confirmed by the accreditation body (3.2)

3.8

accreditation scheme

rules and processes relating to the accreditation (3.1) of conformity assessment bodies to which the same requirements apply

Note 1 to entry: Accreditation scheme requirements include, but are not limited to, ISO/IEC 17020, ISO/IEC 17021, ISO/IEC 17025, ISO/IEC 17024, ISO 17034, ISO/IEC 17043, ISO/IEC 17065, ISO 15189 and ISO 14065.

3.9

accreditation activity

individual operational tasks of the accreditation process (3.11)

Note 1 to entry: See Clause 7.

3.10

impartiality

presence of objectivity

Note 1 to entry: Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the accreditation body (3.2) .

Note 2 to entry: Other terms that are useful in conveying the element of impartiality include “independence”, “freedom from conflict of interests”, “freedom from bias”, “lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”, “even-handedness”, “detachment”, “balance”.

[SOURCE:ISO/IEC 17021‑1:2015, 3.2, modified — The words “certification body” have been replaced by “accreditation body” in Note 1 to entry.]

3.11

accreditation process

activities from application through to granting and maintenance of accreditation (3.1) as defined by the accreditation scheme (3.8)

3.12

accreditation symbol

symbol issued by an accreditation body (3.2) to be used by accredited conformity assessment bodies to indicate they are accredited

3.13

accreditation decision

decision on granting (3.14) , maintaining (3.15) , extending (3.16) , reducing (3.17) , suspending (3.18) and withdrawing (3.19) accreditation (3.1)

3.14

granting accreditation

awarding accreditation (3.1) for a defined scope of accreditation (3.6)

3.15

maintaining accreditation

confirming the continuance of accreditation (3.1) for a defined scope

3.16

extending accreditation

adding conformity assessment activities to the scope of accreditation (3.6)

3.17

reducing accreditation

cancelling part of the scope of accreditation (3.6)

3.18

suspending accreditation

putting temporary restrictions in place for all or part of the scope of accreditation (3.6)

3.19

withdrawing accreditation

cancelling accreditation (3.1) for the full scope

3.20

complaint

expression of dissatisfaction, other than appeal (3.21) , by any person or organization, to an accreditation body (3.2) , relating to the activities of that accreditation body or of an accredited conformity assessment body (3.4) ここで, a response is expected

[SOURCE:ISO/IEC 17000:2004, 6.5, modified — The words “to a conformity assessment body or accreditation body, relating to the activities of that body” have been replaced by “to an accreditation body, relating to the activities of that accreditation body or of an accredited conformity assessment body”.]

3.21

appeal

request by a conformity assessment body (3.4) for reconsideration of any adverse accreditation decision (3.13) related to its desired accreditation (3.1) status

3.22

assessment

process undertaken by an accreditation body (3.2) to determine the competence of a conformity assessment body (3.4) , based on standard(s) and/or other normative documents and for a defined scope of accreditation (3.6)

3.23

reassessment

assessment (3.22) performed to renew the accreditation (3.1) cycle

3.24

assessment technique

method used by an accreditation body (3.2) to perform an assessment (3.22)

3.25

witnessing

observation by the accreditation body (3.2) of a conformity assessment body (3.4) carrying out conformity assessment activities within its scope of accreditation (3.6)

3.26

remote assessment

assessment (3.22) of the physical location or virtual site of a conformity assessment body (3.4) , using electronic means

Note 1 to entry: A virtual site is an online environment allowing persons to execute processes, e.g. in a cloud environment.

3.27

assessment programme

set of assessments (3.22) consistent with a specific accreditation scheme (3.8) that the accreditation body (3.2) performs on a specific conformity assessment body (3.4) during an accreditation (3.1) cycle

3.28

assessment plan

description of the activities and arrangements for an assessment (3.22)

[SOURCE:ISO 19011:2011, 3.15, modified — The word “audit” has been replaced by “assessment”.]

3.29

accreditation body personnel

internal or external individuals carrying out activities on behalf of the accreditation body (3.2)

3.30

assessor

person assigned by an accreditation body (3.2) to perform, alone or as part of an assessment team, an assessment (3.22) of a conformity assessment body (3.4)

3.31

team leader

assessor (3.30) who is given the overall responsibility for the management of an assessment (3.22)

3.32

technical expert

person assigned by an accreditation body (3.2) , working under the responsibility of an assessor (3.30) , who provides specific knowledge or expertise with respect to the scope of accreditation (3.6) to be assessed and does not assess independently

Note 1 to entry: A technical expert is not expected to have assessor qualifications and training.

3.33

interested party

person or organization with a direct or indirect interest in accreditation (3.1)

Note 1 to entry: Direct interest refers to the interest of those who undergo accreditation; indirect interest refers to the interests of those who use or rely on accredited conformity assessment bodies.

Note 2 to entry: Interested parties can include the accreditation body (3.2) , conformity assessment bodies, their associations and their clients, industry services, trade associations, scheme owners, governmental regulatory bodies or other governmental services, or non-governmental organizations, including consumer organizations.

3.34

consultancy

participation in any of the activities of a conformity assessment body (3.4) subject to accreditation (3.1)